Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
Healthy Volunteers
NCT02821741

Effects of External Ear Stimulation on Pain Perception and Mood

Led by National Center for Complementary and Integrative Health (NCCIH) · Updated on 2026-04-14

76

Participants Needed

1

Research Sites

545 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: The vagus nerve runs from the brain to many organs. Stimulating it can affect the experience of pain. The nerve can be stimulated on the surface of the left ear. Researchers want to study how this stimulation affects the perception of pain. They also want to study how mood affects the experience of pain. Objective: To study the effects of mood and vagus nerve stimulation on the experience of pain. Eligibility: Healthy people ages 18 and older who are fluent in English Design: Participants will be pre-screened with a 15-minute phone call. Participants will have three 2-hour visits. At the screening visit, participants will be screened with: Medical and psychiatric history Physical and psychological exams Questionnaires about physical and psychiatric health and mood Urine tests A heat probe on the forearm. The temperature will be increased until it is painful but tolerable. Participants will have 2 testing sessions within 7 days. Before the testing, they cannot do the following: Eat, use nicotine, or exercise for at least 2 hours Drink alcohol for 24 hours Take certain medicines for 3 days Testing includes: Urine drug screening Left ear stimulation: In one session, the vagus nerve will be stimulated. In the other, an area of the ear away from the vagus nerve will be stimulated. This will be done with mild electric shocks that cause a tingling, pricking, or itchy feeling. Heat applied to the forearm until it is painful but tolerable Completing several forms on a computer or on paper about how they are feeling Monitors on the chest and a finger clip to monitor heart, breathing, and blood pressure

CONDITIONS

Official Title

Effects of External Ear Stimulation on Pain Perception and Mood

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 18 and 50 years old
  • Fluent in English
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Unable to follow study procedures or schedule the second session within 10 business days
  • Pregnant or breastfeeding
  • Ear structures not clearly defined due to malformations, accidents, or piercings
  • Skin conditions like scars, burns, or tattoos in the testing area within the past four weeks
  • Women consuming more than 7 alcoholic drinks per week or men more than 14
  • Current or past chronic pain lasting more than six months within the past year
  • Major medical conditions such as kidney, liver, cardiovascular, autonomic, pulmonary, neurological problems, or diabetes
  • Psychiatric disorders including major depression, anxiety, PTSD, bipolar disorder, psychosis, or substance abuse
  • Conditions affecting heart function or peripheral vascular sensitivity
  • Taking medications that affect pain or autonomic function, including opioids, antidepressants, anticonvulsants, or blood pressure medicines, unless stopped for at least one month
  • Heat pain threshold above 46 degrees Celsius
  • Previous acupuncture in or around the ears
  • Employees related to the investigators or NIH staff
  • Consumed alcohol within 24 hours or signs of intoxication
  • Exercised or eaten within 2 hours before testing
  • Used nicotine products within 2 hours before testing
  • Applied topical pain creams within 24 hours before testing
  • Used NSAIDs, acetaminophen, or similar drugs within 3 days before testing

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

H

Hayley A Owens

CONTACT

A

Alisa J Johnson

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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